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ePatch 2.0 Sensor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 02-01650Model ePatch 2.0Ref 02‐01507
Identity
- Trade Name
- ePatch 2.0 Sensor EUDAMEDePatch EUDAMEDePatch 2.0 BTI FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- ePatch 2.0 ECG Recorder EUDAMEDePatch ECG Electrode EUDAMED
- Model / Reference
- ePatch 2.0 EUDAMED02-01650 EUDAMEDFDA UDI02‐01507 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B146EP2020 EUDAMEDFDA UDIB146EPE21 EUDAMED
- Basic UDI-DI
- B-B146EP2020 EUDAMED++B146PatchElectrodeHC EUDAMED
- 510(k) Number
- K171410 FDA UDI
- FDA Product Code
- DSH FDA UDI
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMEDC020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
EUDAMEDEUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ePatch 2.0 Sensor by Braemar Manufacturing, LLC — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-B146EP2020 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-B146EP2020 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Braemar Manufacturing, LLC
- EUDAMED SRN
- US-MF-000036101
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED 34880c14-c4d6-45de-aa3b-efd84e72c63c 61 fields · synced Jul 9, 2026
- EUDAMED 93a0587e-13fb-4b56-93ac-235dc33fdfc7 61 fields · synced May 18, 2026
- FDA UDI 00d03d6b-2fe9-4fd3-be0b-5758653bece6 33 fields · synced May 30, 2026